Regulatory Affairs Director

7 days ago


Menlo Park, California, United States Lifelancer Full time

Lead Regulatory Affairs efforts for Orca Bio, a late-stage biotechnology company developing cell therapies.

The ideal candidate will have 12+ years of regulatory experience, including 8+ years in leadership within the biotech/pharmaceutical industry or as a seasoned regulator.

We offer a competitive salary range of $180,000 - $250,000 based on prior experience, education, location, and internal equity.

About the Job

This role will lead the development and submission of regulatory documents, serve as the primary point of contact for regulatory agencies, and build the Regulatory Affairs team.

  • Develop and execute regulatory strategies to ensure compliance with current global regulations and anticipate changes in regulatory landscapes.
  • Liaise with R&D, clinical development, and commercial teams to ensure regulatory alignment with business objectives.
  • Prepare and participate in key regulatory meetings, including pre-IND, End-of-Phase 1/2, and pre-BLA meetings.
Requirements

To be successful, you'll need:

  • A minimum of 12+ years of regulatory affairs experience, including 8+ years in a leadership capacity within the biotech/pharmaceutical industry, or as a seasoned regulator.
  • An advanced degree (PharmD, PhD, MD) in biology/life sciences/or related discipline.
  • Prior experience interacting with the FDA and successfully filing late-stage regulatory submissions.
  • Prior experience working in a clinical regulatory leadership role in a small biotech environment.
About Orca Bio

Orca Bio is a driven organization by passion for science and compassion for patients. We act with urgency to ensure our treatments are accessible to all who need them.

We're an equal opportunity employer, recognizing that celebrating our differences creates stronger, lasting solutions that better serve our team, patients, and healthcare providers.



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